Parexel Hiring fresers for Clinical Data Analyst I @Bengaluru/ Hyderabad
The Clinical Data Analyst I (CDA I) works under the guidance and supervision of their Line Manager and/or Subject Matter Experts to perform clinical data cleaning activities on assigned projects. Responsibilities include supporting data processing activities, managing Data Management documents, and data cleaning matrices such as Data Validation specification, CRF Completion Guidelines, Protocol Deviation Specification, and Mock Shell for Off-line listing. All tasks must adhere to corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP, and other international regulatory requirements.
Position Name : Clinical Data Analyst I (CDA I)
Organization : Parexel
Qualification: Bachelor’s degree and/or other medical qualifications
Experience: Freshers & Experience
Salary: N/A
Location: Bengaluru/Hyderabad
Clinical Data Analyst I
Location:
- Bengaluru, Karnataka, India
- Additional Locations: Hyderabad, Telangana, India
-
Job ID: R0000025438
Key Responsibilities:
Data Validation (Cleaning):
- Lead data cleaning and data review activities, including query management and manual/SAS listing reviews.
- Support and lead data processing activities from database setup to database lock, including external vendor data reconciliation.
Data Management Documents/Plans (Trial Master File):
- Perform and support the setup of Data Management documents, ensuring proper documentation as per SOPs and ICH/GCP Guidelines.
Study Start-Up Activities and User Acceptance Testing (UAT):
- Lead and perform user acceptance testing on clinical database setups.
- Review protocols and EDC Entry Screens as required.
Data Tracking and Entry:
- Track and review CRFs.
- Support data entry where necessary.
Project Quality Management & Compliance:
- Ensure compliance with Standard Operating Procedures and ICH/GCP Guidelines.
- Lead functional QC activities on databases and/or patient data as per business needs.
Training:
- Maintain training compliance as per job roles assigned, including On-the-Job training.
- Address training needs as identified in Development Goals.
Skills:
- Strong problem-solving skills and logical reasoning.
- Commitment to first-time quality, attention to detail.
- Time management and prioritization skills to meet objectives and timelines.
- Ability to work collaboratively within a team environment.
- Good interpersonal, oral, and written communication skills.
- Ability to learn quickly and share knowledge.
- Flexible attitude towards work assignments and new learning.
- Accountability for key responsibilities outlined in the job description.
- Fluency in English (written and oral).
Knowledge and Experience:
- Technical aptitude with basic computer skills in Microsoft Office Products.
- Basic understanding of data management processes and data validation flow.
- Familiarity with ICH-GCP Guidelines, local regulatory requirements, PAREXEL SOPs, and study-specific procedures.
- Knowledge of Clinical Data Management Systems (e.g., InForm, Rave, Veeva, Datalabs, ClinBase).
- Understanding of Clinical Study Team roles within Data Management.
- Experience in the clinical research industry.
- Knowledge of medical terminology and coding dictionaries (e.g., MedDRA & WHODRUG).
- Awareness of Data Management Operational processes and tasks during study start-up, conduct, and close-out.
- Knowledge of Database setup activities, including Database Configuration Specifications and setup of Data Validation.
Education:
- Bachelor’s degree and/or other medical qualifications or relevant industry experience.
Work Location:
- Office-based in Bengaluru or Hyderabad.
Application Link
https://chat.whatsapp.com/DO9PMPj2H3K4SikyHri52x
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